B Veritor System Reader Reader User’s Manual

1 B Veritor System ReaderReader user s ManualEnglish: pages 1 10 Portugu s: P ginas 50 59 Fran ais : pages 11 20 аза : Беттер 60 70 Deutsch: Seiten 21 30 Русский: Страницы 70 81 Italiano: pagine 31 40 Укра нський: Стор нки 81 91 Espa ol: p ginas 40 49Свържете се с местния представител на BD за инструкзии. / Pokyny v m poskytne m stn z stupce spole nosti BD. / Kontakt den lokale BD repr sentant for at f instruktioner. / BD . / Kasutusjuhiste suhtes kontakteeruge oma kohaliku BD esindajaga. / Ota yhteys l himp n BD:n edustajaan ohjeiden saamiseksi. / Kontaktiraj lokalnog predstavnika BD za upute. / A haszn lati utas t st k rje a BD helyi k pviselet t l.

2 / Н с аулар ш н жерг л кт BD к л мен хабарласы ыз. / Naudojimo instrukcij teiraukit s vietos BD galiotojo atstovo. / Neem contact op met uw plaatselijke BD-vertegenwoordiger voor instructies. / Kontakt din lokale BD-representant for mer informasjon. / Aby uzyska instrukcje u ytkowania, skontaktuj si z lokalnym przedstawicielstwem BD. / Contacte o representante local da BD para instru es. / Pentru instruc iuni, contacta i reprezentantul local BD. / Для получения указаний обратитесь к местному представителю компании BD. / In trukcie z skate u miestneho z stupcu spolo nosti BD. / Obratite se svom lokalnom predstavniku kompanije BD za uputstva. / Kontakta n rmaste BD-representant f r anvisningar. / Talimatlar i in yerel BD temsilcinizle temasa ge USEThe BD Veritor System Reader is for use with BD Veritor System Test Kit AND EXPLANATIONThe BD Veritor System Reader is a reflectometric Reader that is part of the BD Veritor System .

3 The BD Veritor System Reader detects the insertion of a BD Veritor System Test Kit Device and reads the device barcode to detect the assay type. Once it registers the assay type, the Reader illuminates the device read window and measures the intensity of the control and analyte lines. Operator visual readings of the assay lack the sensitivity and objectivity of the Reader , therefore assay result determination by operator visual readings of the BD Veritor System Test Kit Devices is not intended as part of the BD Veritor OF THE PROCEDUREThe BD Veritor System Reader is an optoelectronic instrument that uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and a specific algorithm to determine the presence or absence of any target analyte(s).

4 The Reader determines the line intensity at each of the spatially-defined test and control line positions, interprets the results using a scoring algorithm, and reports a positive, negative, or invalid result based on pre-set thresholds. A liquid crystal display UL010108(03) 2013-092(LCD) on the instrument communicates status and results to the operator. The Reader supports the use of different assays by reading an assay-specific barcode on the test device. The instrument is maintenance free and is configured with a single button design (power switch). Reader EXPIRATIONThe Reader is not configurable by the user and is designed to have a finite lifetime based on the number of tests performed, the number of days from first use by the end user , or a maximum shelf-life from the date of manufacture, whichever occurs first.

5 Number of tests performed = 3000 tests maximum. Number of months from first use by the end user = a minimum of 22 months (670 days) up to a maximum of 24 months (730 days). Maximum shelf-life from the date of manufacture (regardless of use) = 34 months (1034 days).WARNINGS AND PRECAUTIONS For in vitro Diagnostic Use. Do not use after expiration date. Dispose of used BD Veritor System Test Kit Devices as biohazardous waste. Dispose of expired BD Veritor System Readers as biohazardous waste and according to local environmental electronic waste disposal regulations. Do not eat, drink, or smoke in the area where the specimens and kits are handled. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens.

6 Standard Precautions 1-4 and institutional guidelines for the handling of biohazardous materials should be followed in handling all items contaminated with blood and other body fluids. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are processed. Humidity and temperature can adversely affect results; therefore, operate the BD Veritor System Reader indoors at room temperature (15 30 C). Protection provided by this equipment may be impaired if the equipment is used in a manner not consistent with the instructions in this Manual . Replace the batteries in the BD Veritor System Reader with two new AA non-rechargeable LR6 alkaline batteries. To reduce the risk of fire, do not use rechargeable batteries, lithium ion batteries, or other non-alkaline battery types in the BD Veritor System Reader .

7 Note that the diagnostic port inside of the battery chamber is for BD use only. The plug on the diagnostics port should not be removed, nor should any cables be plugged into the BD Veritor System Reader . Ensure that the BD Veritor System Reader is not in direct sunlight or exposed to a bright light. The BD Veritor System Reader is designed for use only with BD Veritor System Test Kit Devices. Do not insert any foreign materials into the BD Veritor System FOR SET-UPBox Contents 1 BD Veritor System Reader 1 user s Manual 1 BD Veritor System Verification Cartridge 2 AA non-rechargeable LR6 alkaline batteries (installed)NOTE: If any items are missing, contact your BD representative or BD Technical and Setup1.

8 Before using the BD Veritor System Reader , visually inspect the contents for damage. If damage is apparent, contact your BD representative or BD Technical Remove the Reader from its protective wrapping. BD recommends retaining the packaging materials in a safe Perform a verification test as described in the BD Veritor System Verification Cartridge InstallationThe Reader requires two AA non-rechargeable LR6 alkaline batteries such as DURACELL Coppertop MN1500 AA LR6, Eveready Energizer E91 Alkaline AA Cell LR6 AM3, or equivalent. To reduce the risk of fire, do not use rechargeable batteries, lithium ion batteries, or other non-alkaline battery types in the BD Veritor System Using slight thumb pressure, slide the battery door, located on the bottom of the Reader , toward the front as shown in Figure 1.

9 Remove the Remove the existing batteries and discard according to local environmental electronic waste disposal Install the new batteries as shown in Figure 1. Ensure that the polarity orientation is correct as shown in Figure Reinstall the battery that the diagnostic port inside the battery chamber is for BD use only. The plug on the diagnostics port should not be removed, nor should any cables be plugged into the BD Veritor System 1 Battery AccessPROCEDURES FOR USEThe BD Veritor System Reader is intended for use with the BD Veritor System Test Kit. Specific instructions and expiration dating (format: YYYY-MM-DD) can be found in the labeling included with each BD Veritor System Test Place the BD Veritor System Reader on a flat, dry, stable Ensure that the BD Veritor System Reader is not in direct sunlight or exposed to a bright Check the BD Veritor System Reader for an inserted device.

10 If a device is present, remove it from the BD Veritor System Press the front panel power button. The BD Veritor System Reader must complete a 5 second self-test before it is ready for use. 5. When the display window reads INSERT TEST, insert a BD Veritor System device into the slot on the right side of the Reader as shown in Figure 2, aligning the insertion arrow on the device with the insertion arrow on the Reader . Insert the device all the way in until it stops. A distinctive click will be felt when the device is properly engaged in the The display will show remaining read time as the read is performed. The read duration of the BD Veritor System Reader is approximately 10 seconds. Do not touch the BD Veritor System Reader or remove the BD Veritor System Test Kit Device during this When the read is complete, the test result will be displayed with the name of the test and a + or symbol to indicate positive test or negative test, respectively.